Clinical Trial Research Project Manager - Beat Childhood Cancer Research Consortium
- CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday.
- CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday.
- If you are NOT a current employee or student, please click "Apply" and complete the application process for external applicants.
JOB DESCRIPTION AND POSITION REQUIREMENTS:
The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Coordinator. The Beat Childhood Cancer Research Consortium (BCC) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This position supports clinical trial research across these 50+ hospital sites and has a specialized focus on research project operations including study methodologies, protocol development, logistical support, project management and timelines.
For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org)
Job Duties and Responsbilities:
Protocol Management
- Reviews and provides approval for the enrollment of study participants based on inclusion/exclusion criteria onto active BCC clinical trials from participating study sites.
- Oversees and advises on research projects from study initiation to conclusion including study design, data collection, management plans. Performing phase I and phase II protocol reviews to identify potential concerns and recommending improvements before release of protocol to the study sites.
- Designs and manages work-flow processes for required and supporting documents for study protocols to maintain data accuracy.
- Uses existing practices as a foundation to build upon to improve work-flow processes internally and externally for each protocol.
- Collaborates with internal team daily utilizing medical knowledge to review and ensure accuracy and safety in the protocol development, process of data collection and study design and oversight.
- Maintain up-to-date knowledge of and promote understanding and compliance with relevant laws and regulations.
Safety Monitoring and Management
- Oversees study data collection including quality assurance by querying and maintaining contact with study sites.
- Monitors and manages appropriate documentation internally and externally all Serious Adverse Events for all study sites required for FDA and other regulatory reporting.
- Author, review and revise standard operating procedures for maintenance of clinical research operations.
Other
- Supervise and mentor Clinical Research Coordinators
- Maintain positive relationships and interactions with clinical investigators and staff through frequent contact and prompt replies to requests or concerns.
- Flexibility to adapt to changing circumstances.
- Excellent organizational skills, multitasking and communication both written and spoken.
- Attend conferences and trainings, as needed.
The ideal candidate will have a strong background in Clinical Trial Management, Human Subjects Research, and IND or IDE Safety Reporting. It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork.
This is a limited-term position funded for one year from date of hire, withpossibility of refunding.
Master's Degree
3+ years of relevant experience
Or an equivalent combination of education and experience
Nursing or Clinical Trial Management Advanced Degree preferred.
The following clearances must be successfully completed for this position:
- Pennsylvania State Police Criminal Background Check
- Pennsylvania Child Abuse History
- Federal Bureau of Investigation (FBI) Criminal Background Check
The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion inall ofits forms.We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission.
The salary range for this position, including all possible grades is:
$68,200.00 - $102,300.00
APPLICATION INSTRUCTIONS:
- CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday.
- CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday.
- If you are NOT a current employee or student, please click "Apply" and complete the application process for external applicants.
JOB DESCRIPTION AND POSITION REQUIREMENTS:
The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Coordinator. The Beat Childhood Cancer Research Consortium (BCC) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This position supports clinical trial research across these 50+ hospital sites and has a specialized focus on research project operations including study methodologies, protocol development, logistical support, project management and timelines.
For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org)
Job Duties and Responsbilities:
Protocol Management
- Reviews and provides approval for the enrollment of study participants based on inclusion/exclusion criteria onto active BCC clinical trials from participating study sites.
- Oversees and advises on research projects from study initiation to conclusion including study design, data collection, management plans. Performing phase I and phase II protocol reviews to identify potential concerns and recommending improvements before release of protocol to the study sites.
- Designs and manages work-flow processes for required and supporting documents for study protocols to maintain data accuracy.
- Uses existing practices as a foundation to build upon to improve work-flow processes internally and externally for each protocol.
- Collaborates with internal team daily utilizing medical knowledge to review and ensure accuracy and safety in the protocol development, process of data collection and study design and oversight.
- Maintain up-to-date knowledge of and promote understanding and compliance with relevant laws and regulations.
Safety Monitoring and Management
- Oversees study data collection including quality assurance by querying and maintaining contact with study sites.
- Monitors and manages appropriate documentation internally and externally all Serious Adverse Events for all study sites required for FDA and other regulatory reporting.
- Author, review and revise standard operating procedures for maintenance of clinical research operations.
Other
- Supervise and mentor Clinical Research Coordinators
- Maintain positive relationships and interactions with clinical investigators and staff through frequent contact and prompt replies to requests or concerns.
- Flexibility to adapt to changing circumstances.
- Excellent organizational skills, multitasking and communication both written and spoken.
- Attend conferences and trainings, as needed.
The ideal candidate will have a strong background in Clinical Trial Management, Human Subjects Research, and IND or IDE Safety Reporting. It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork.
This is a limited-term position funded for one year from date of hire, withpossibility of refunding.
Minimum Education & Experience
Nursing or Clinical Trial Management Advanced Degree preferred.
The following clearances must be successfully completed for this position:
- Pennsylvania State Police Criminal Background Check
- Pennsylvania Child Abuse History
- Federal Bureau of Investigation (FBI) Criminal Background Check
The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion inall ofits forms.We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission.
The salary range for this position, including all possible grades is:
$68,200.00 - $102,300.00
Salary Structure - additional information on Penn State's job and salary structure.
CAMPUS SECURITY CRIME STATISTICS:
Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here.
Employment with the University will require successful completion of background check(s) in accordance with University policies.
EEO IS THE LAW
Penn State is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473.
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